{"entity":{"id":"nct00769704","kind":"trial","name":"Efficacy and Safety Study of Talimogene Laherparepvec Compared to Granulocyte Macrophage Colony Stimulating Factor (GM-CSF) in Melanoma","aka":[],"tldr":"A phase 3 trial of Talimogene laherparepvec and Sargramostim in Melanoma, run by BioVex Limited, completed.","summary":"Efficacy and Safety Study of Talimogene Laherparepvec Compared to Granulocyte Macrophage Colony Stimulating Factor (GM-CSF) in Melanoma is a phase 3 interventional study registered as NCT00769704 by BioVex Limited, with 437 participants recorded, started 2009-04 and reaching its primary completion in 2013-02. Interventions recorded: Talimogene laherparepvec, GM-CSF. Conditions recorded: Melanoma.\n\nLinked to the drug Talimogene laherparepvec because the registry names it among its interventions and Melanoma among its conditions. Registry record only: no result has been read by an editor.","status":"completed","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT00769704","url":"https://clinicaltrials.gov/study/NCT00769704"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["melanoma","advanced-melanoma"],"sections":[],"technologies":[],"targets":[],"drugs":["talimogene-laherparepvec","sargramostim"],"companies":["amgen"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT00769704","phase":"3","setting":"A Randomized Phase 3 Clinical Trial to Evaluate the Efficacy and Safety of Treatment With OncoVEX^GM-CSF Compared to Subcutaneously Administered GM-CSF in Melanoma Patients With Unresectable Stage IIIb, IIIc and IV Disease","sponsor":"BioVex Limited","started":"2009-04","yearReported":2015,"enrolled":437,"enrolledBasis":"registry","outcomes":[{"endpoint":"Durable Response Rate","primary":true,"unit":"%","arms":[{"name":"GM-CSF","n":141,"value":2.1,"note":"95% CI 0.0 to 4.5; Figures from the ClinicalTrials.gov results section (first posted 2015-12-17), not from a publication"},{"name":"Talimogene Laherparepvec","n":295,"value":16.3,"note":"95% CI 12.1 to 20.5"}],"p":"<0.0001","source":"https://clinicaltrials.gov/study/NCT00769704?tab=results"},{"endpoint":"Overall Survival","unit":"months","arms":[{"name":"GM-CSF","n":141,"value":18.9,"note":"95% CI 16.0 to 23.7; Figures from the ClinicalTrials.gov results section (first posted 2015-12-17), not from a publication"},{"name":"Talimogene Laherparepvec","n":295,"value":23.3,"note":"95% CI 19.5 to 29.6"}],"hr":0.79,"ci":[0.62,1],"p":"0.0511","source":"https://clinicaltrials.gov/study/NCT00769704?tab=results"},{"endpoint":"Objective Response Rate","unit":"%","arms":[{"name":"GM-CSF","n":141,"value":5.7,"note":"95% CI 1.9 to 9.5; Figures from the ClinicalTrials.gov results section (first posted 2015-12-17), not from a publication"},{"name":"Talimogene Laherparepvec","n":295,"value":26.4,"note":"95% CI 21.4 to 31.5"}],"p":"<0.0001","source":"https://clinicaltrials.gov/study/NCT00769704?tab=results"}]},"route":"/trials/nct00769704/","neighbours":{"cancer":[{"id":"advanced-melanoma","kind":"cancer","name":"Advanced melanoma (unresectable stage III and stage IV)","route":"/cancers/advanced-melanoma/"},{"id":"melanoma","kind":"cancer","name":"Melanoma","route":"/cancers/melanoma/"}],"drug":[{"id":"sargramostim","kind":"drug","name":"Sargramostim","route":"/drugs/sargramostim/"},{"id":"talimogene-laherparepvec","kind":"drug","name":"Talimogene laherparepvec","route":"/drugs/talimogene-laherparepvec/"}],"company":[{"id":"amgen","kind":"company","name":"Amgen","route":"/companies/amgen/"}]}}